FDA issues draft guidance on nanotechnology

Two
draft guidance documents that address the use of nanotechnology by the
food and cosmetics industries were issued on Friday, April 20, by the U.S. Food and
Drug Administration.

Nanotechnology
is an evolving technology that allows scientists to create, explore,
and manipulate materials on a scale measured in nanometers—particles so
small that they can not be seen with a regular microscope. The
technology has a broad range of potential applications, such as the
packaging of food or altering the look and feel of cosmetics.

The
two draft guidance documents are: “Guidance for Industry: Assessing the
Effects of Significant Manufacturing Process Changes, including
Emerging Technologies, on the Safety and Regulatory Status of Food
Ingredients and Food Contact Substances, Including Food Ingredients that
are Color Additives” and “Guidance for Industry: Safety of
Nanomaterials in Cosmetic Products.”

The
food draft guidance describes the factors manufacturers should consider
when determining whether changes in manufacturing processes, including
those involving nanotechnology, create a significant change that may:

affect the identity of the food substance;

affect the safety of the use of the food substance;

affect the regulatory status of the use of the food substance; or

warrant a regulatory submission to FDA.

The
cosmetic product draft guidance discusses the FDA’s current thinking on
the safety assessment of nanomaterials when used in cosmetic products.
Key points include:

The
legal requirements for cosmetics manufactured using nanomaterials are
the same as those for any other cosmetics. While cosmetics are not
subject to premarket approval, companies and individuals who market
cosmetics are legally responsible for the safety of their products and
they must be properly labeled.

To
conduct safety assessments for cosmetic products containing
nanomaterials, standard safety tests may need to be modified or new
methods developed.

Both
guidances encourage manufacturers to consult with the agency before
taking their products to market. Such consultation can help FDA experts
address questions related to the safety or other attributes of
nanotechnology products, or answer questions about their regulatory
status.

Strong
science is critical to FDA’s ongoing review of the products it
regulates. FDA is investing in an FDA-wide nanotechnology regulatory
science program to further enhance FDA’s scientific capabilities,
including developing necessary data and tools to identify properties of
nanomaterials and assess the impact they may have on products.

“Understanding
nanotechnology remains a top FDA priority. FDA is strengthening the
scientific tools and methods for evaluating food products, cosmetics,
drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg,
M.D. “We are taking a prudent scientific approach to assess each product
on its own merits and to not make broad, general assumptions about the
safety of nanotechnology products.”

The
FDA’s current thinking concerning nanomaterials for food and cosmetics
uses, explained in the two guidance documents, is not intended to
provide guidance to manufacturers about the use of nanomaterials in
other products, such as drugs or medical devices, regulated by the FDA.

In
order to ensure that FDA considers comments on these draft guidances in
developing the final guidances, electronic or written comments should
be submitted within 90 days of the publication of the notices of
availability in the Federal Register. The FDA will carefully consider
all relevant, substantive comments during the development of the final
guidance documents.

Electronic
comments should be submitted to http//www.regulations.gov. Written
comments should be submitted to the Division of Dockets Management,
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,
Rockville, MD 20852.